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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37603
Device Problem Communication or Transmission Problem
Event Date 07/21/2015
Event Type  Malfunction  
Manufacturer Narrative

Product id 3389s-40, lot# va0w79v, implanted: 2015 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2015 (b)(6); product type extension product id 37642, serial# (b)(4); product type programmer, patient product id 3389s-40, lot# va0w79v, implanted: 2015 (b)(6); product type lead. (b)(4).

 
Event Description

A consumer reported that a poor communication screen was displayed on the patient programmer and the patient was getting poor communication. The patient was recently implanted and bandages and some swelling was present. On the day of this report, the patient met with a nurse for their health care provider and they turned down settings a little bit. Since the settings were turned down, the patient's hand was shaking really bad and the shaking was terrible. The shaking had started the day prior to this report and had gone away, but it was back today. The patient only had shaking in their hand and it was gradually getting worse. On 2015 (b)(6), the patient had cramping in their leg. The patient's indication for use is essential tremor and movement disorders. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Additional information received from a consumer reported the patient had contacted their health care provider (hcp) about the shaking and leg cramping. The patient had an appointment scheduled for 2015 (b)(6). The patient's daughter was able to turn stimulation up and down for the patient, but they could not seem to get it in the right spot. The resolve the patient's shaking, they had been taking more medication and they had turned stimulation up. The patient was working with their hcp for their leg.

 
Manufacturer Narrative

(b)(4).

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55432
7635263987
MDR Report Key5010764
Report Number3004209178-2015-16200
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/24/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/18/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/28/2016
Device MODEL Number37603
Device Catalogue Number37603
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/06/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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